Abstract

Background: Evidence regarding using acetylsalicylic acid (aspirin) for the prevention of cardiovascular (CV) events in patients with diabetes mellitus (DM) is inconsistent. Therefore, we performed a meta-analysis.

Methods: A literature search was performed (January 1990 to February 2022) and publications meeting the inclusion criteria were reviewed, and a meta-analysis was performed using RevMan software. The primary outcome was a composite of CV death, non-fatal myocardial infarction (MI) and stroke. Secondary outcomes included all-cause mortality, individual components of the primary outcome and major bleeding.

Results: The study cohort comprised 33525 diabetic patients from 9 randomized controlled trials. The primary outcome was significantly lower for aspirin vs. placebo (7.9 vs. 8.6, RR (risk ratio) 0.92, 95% CI (confidence interval) 0.86-0.99). All-cause mortality (10 vs. 10.3%, RR 0.97, 95% CI 0.90-1.03), CV death (4.4 vs. 4.7%, RR 0.93, 95% CI 0.83-1.04), non-fatal MI (4.6 vs. 4.8% RR 0.97, 95% CI 0.83- 1.15) and stroke (3.2 vs. 3.5%, RR 0.89, 95% CI 0.75-1.06) were similar between the two treatment groups. Major bleeding was significantly higher for aspirin compared with placebo (3.4 vs. 2.8%, RR 1.18, 95% CI 1.01-1.39).

Conclusion: Aspirin use in patients with DM reduces the composite endpoint of CV death, non-fatal MI and stroke compared with a placebo. However, routine use of aspirin for primary prevention among diabetic patients cannot be advised due to the increased risk of major bleeding. These findings suggest careful risk assessment of individual patients.

Graphical Abstract